Oct 12, 2023
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
Read More
Oct 3, 2023
HSA
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...
Read More
Sep 29, 2023
Asia
The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
Read More
Sep 28, 2023
Asia
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. Table of...
Read More
Feb 20, 2023
MDCG
The article provides an overview of the revised guidance document addressing the classification rules. Table Of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework,...
Read More